(28 days)
The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.
The CereLink ICP Monitor is indicated for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:
- Displays ICP Waveform .
- Displays Mean ICP numeric .
- Displays the historic mean pressure as a trend .
- Displays trend statistics (Pressure Time Dosage (PTD) , time above threshold, boxplot, . histogram)
- Stores 14-days' worth of mean ICP values .
- . Stores 24 hours of pressure waveform
- Can capture and store screen-shots 9
- . Can download various data to a USB device for printing or analysis
- Real-time data streaming of mean ICP and waveform via USB connection .
- Connect to external patient monitor .
The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with an CereLink ICP extension cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).
Let's break down the information provided to answer your request.
Based on the provided document, the CereLink ICP Monitor is a device that interfaces with pressure transducers and monitors intracranial pressure. The submission to the FDA (K210993) is for modifications to an existing CereLink ICP Monitor (predicate K183406), not for a brand new device. Therefore, the "study" described is primarily focused on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the original, already cleared device.
Here's the breakdown of acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for modifications to an already cleared device, the "acceptance criteria" are implied to be the successful demonstration that the modifications do not introduce new safety or effectiveness concerns and that the device continues to perform as intended and substantially equivalent to its predicate. The document doesn't list specific quantitative acceptance criteria for clinical performance in the way one might expect for a novel diagnostic algorithm. Instead, it focuses on various engineering and design-related tests to confirm the changes are benign or improvements.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Conclusion) |
|---|---|
| Performance Testing (e.g., ICP accuracy) | Pass |
| Software Integrity and Functionality | Pass |
| Electrical Safety | Pass |
| Electromagnetic Compatibility | Pass |
| Sterilization/Cleaning Requirements | Non-sterile, no change to parameters |
| Shelf-Life | Not applicable (reusable, no expiry) |
| Biocompatibility | Not applicable (non-patient contacting) |
| No new questions of safety and effectiveness | Concluded as substantially equivalent |
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like the CereLink ICP Monitor, which is a physiological measurement and monitoring device, the "test set" and "ground truth" are interpreted differently than for, say, an AI-powered diagnostic imaging tool.
- Test Set/Sample Size: The document refers to various bench tests including "ICP Drift Test," "Common Mode Noise and Leakage Current Power Supply Test," "13 Day Simulated Environment Validation Test," etc. These are engineering validation tests, not clinical studies with patient data in the traditional sense of a "test set." The sample sizes would refer to the number of devices or components tested, but this specific detail is not provided in a summarized form.
- Data Provenance: Not applicable in the context of clinical data for performance validation. The testing seems to be internal engineering verification and validation.
- Experts/Ground Truth/Adjudication Method/MRMC/Standalone Performance: These concepts are largely not applicable here. The CereLink ICP Monitor is not an AI-driven diagnostic device that relies on expert interpretation or establishing a ground truth for diagnostic accuracy (like identifying a lesion on an image). It's a device that measures and displays physiological parameters. The "ground truth" in this context would be the actual physical/electrical properties that the device is designed to measure and the expected behavior under various conditions (e.g., drift, noise, safety limits). The study's focus is on validating the device's performance against these engineering and safety standards, not on its diagnostic accuracy based on expert consensus.
The document explicitly states:
- "No clinical studies were required."
- "Appropriate verification of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, electrical safety, and electromagnetic compatibility testing."
- "The CereLink ICP Monitor is a reusable, non-sterile device. There is no expiry date and shelf-life is not applicable for this device."
- "The CereLink ICP Monitor is non-patient contacting. Therefore, biocompatibility is not applicable for this device."
- "No animal studies were required."
This indicates that the "study" primarily consisted of bench testing and engineering verification and validation to confirm that the technical modifications (power supply, internal components, software updates, etc.) did not compromise the device's ability to accurately measure ICP, maintain electrical safety, and function reliably.
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are not applicable as the CereLink ICP Monitor is not described as an AI/machine learning device that requires a training set. The modifications described are hardware and software updates to an existing physiological monitoring device, not the development of a predictive algorithm using a "training set."
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).